Robotic Modified Constraint -Induced Therapy in Patients With Spastic

Status Completed

Clinical Trial Summary

Background and purpose: Botulinum toxin A (BoNT-A) injection is effective in reducing spasticity. However, the optimal training program post BoNT-A injection remains uncertain. Constraint-induced movement therapy (CIMT) is the most investigated intervention with promising effects for improving upper extremity (UE) function and increasing use frequency of the affected limb in ADL. The CIMT has strict inclusion criteria, which might not be suitable for a majority of patients who have moderate to severe spasticity. The aims of this study are to compare the effect of Robotic mCIMT with conventional upper extremity rehabilitation training in patient with spastic hemiplegia post BoNT-A injection. Methods: Those patients with spastic hemiplegic stroke will receive BoNT-A injection and then be randomly assigned to either Robotic mCIMT group (1 hour unilateral robotic therapy, followed by 30 minutes of functional practice of affected UE using shaping technique, 3/week for 8 weeks and restraint of the unaffected limb at home for 2 hrs per day ) or control group (conventional upper extremity rehabilitation training 1.5 hours per session, 3/week for 8 weeks and home exercise 2 hrs per day). Body function and structures outcome measures, such as Fugl-Meyer Assessment, Actigraph ; activity and participation measures, such as Wolf Motor Function Test, Motor Activity Log, will be assessed before, after intervention, and 3 months post-intervention. Investigators will also monitor the kinematic data of InMotion 3.0 robot across the whole course of Robotic mCIMT to see how the Robotic mCIMT following BoNT-A injection impacts motor learning process of the participants. Analysis: To evaluate the treatment effects of the outcome measures, 2 groups (Robotic mCIMT or control) * 3 times (before intervention, after intervention, and 3 months after intervention) repeated-measure ANOVA will be used.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03807557
Study type	Interventional
Source	Chang Gung Memorial Hospital
Contact
Status	Completed
Phase	N/A
Start date	January 30, 2019
Completion date	December 30, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Robotic Modified Constraint -Induced Therapy in Patients With Spastic Hemiplegic Stroke Post Botulinum Toxin A Injection

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms